Back to resultsMind/Body Medicine and IBD Flare-Up
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mind/Body Courses
Sponsored by
About this trial
This is an interventional prevention trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, IBD Flare-Up, Stress
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of moderately severe Ulcerative Colitis
- Age 18-70
- Must have inactive disease at the time of recruitment, with at least one documented disease flare-up within the past 2 years.
- Must be on either no IBD medication or have been on a stable dose of any of the following medications for the specified amount of time: Mesalamine or Sulfasalazine for at least 6 weeks; Remicade for at least 10 weeks; Imuran or Mercaptopurine at stable and unchanged dose for at least 8 weeks.
Exclusion Criteria:
- Active Ulcerative Colitis or daily rectal bleeding for 7 days
- Taking oral steroids within 30 days of enrollment, topical agents (steroids or 5-ASA) within 14 days,immunomodulators such as Methotrexate or Imuran/6-MP and Infliximab within 90 days
- History of colon resection
- Antibiotics use within the previous 14 days
- Pregnant or lactating women
- Significant chronic disorders like severe cardiac disease (NY functional state score>3), renal disease (creatinine>3 mg/dL), pulmonary disease (shortness of breath at rest or need for oxygen use), active infection, or other organ system disease requiring medical visits > 3 times /year
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental
Other
Arm Description
Mind/Body Course
Mind/Body Course
Outcomes
Primary Outcome Measures
gut inflammation assessed by stool Calprotectin
Secondary Outcome Measures
Gut oxidative tissue injury assessed by mucosal protein oxidation (protein carbonyl)
stress responses assessed by 24h urinary cortisol and psychological questionnaire
prevention of flare-up assessed by IBD-related clinical, endoscopic, and histological indices
Full Information
NCT ID
NCT00568256
First Posted
December 4, 2007
Last Updated
February 24, 2012
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00568256
Brief Title
Mind/Body Medicine and IBD Flare-Up
Official Title
Mind/Body Medicine and IBD Flare-Up
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Ulcerative Colitis is an Inflammatory Bowel disease that is a life-long, relapsing disabling disorder. Current treatments for Ulcerative Colitis are not satisfactory. Most medications provide only partial relief, are not successful for at least 30% of patients, and have major negative side effects. Mounting evidence indicates that stress is one of the important triggers that activates symptoms of ulcerative colitis and therefore causes flare-up. The primary aim of this study is to see if either of two 8-week Mind-Body courses has an effect in reducing stress and affecting the course and severity of UC.
Hypotheses: Stress causes Ulcerative Colitis flare-up and stress reduction will prevent Ulcerative Colitis flare-up.
Detailed Description
Methods: We will enroll 100 subjects in a Phase I/IIa randomized, double-blind, placebo-controlled trial. Subjects will be assigned to one of two Mind/Body courses, each of which will be held once a week for 8 consecutive weeks. Each class will last 1.5-2 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis, IBD Flare-Up, Stress
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Mind/Body Course
Arm Title
Other
Arm Type
Other
Arm Description
Mind/Body Course
Intervention Type
Behavioral
Intervention Name(s)
Mind/Body Courses
Intervention Description
8-week Mind/Body course held once a week for 2 hours at a time.
Primary Outcome Measure Information:
Title
gut inflammation assessed by stool Calprotectin
Time Frame
(1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course
Secondary Outcome Measure Information:
Title
Gut oxidative tissue injury assessed by mucosal protein oxidation (protein carbonyl)
Time Frame
(1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course
Title
stress responses assessed by 24h urinary cortisol and psychological questionnaire
Time Frame
(1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course
Title
prevention of flare-up assessed by IBD-related clinical, endoscopic, and histological indices
Time Frame
(1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of moderately severe Ulcerative Colitis
Age 18-70
Must have inactive disease at the time of recruitment, with at least one documented disease flare-up within the past 2 years.
Must be on either no IBD medication or have been on a stable dose of any of the following medications for the specified amount of time: Mesalamine or Sulfasalazine for at least 6 weeks; Remicade for at least 10 weeks; Imuran or Mercaptopurine at stable and unchanged dose for at least 8 weeks.
Exclusion Criteria:
Active Ulcerative Colitis or daily rectal bleeding for 7 days
Taking oral steroids within 30 days of enrollment, topical agents (steroids or 5-ASA) within 14 days,immunomodulators such as Methotrexate or Imuran/6-MP and Infliximab within 90 days
History of colon resection
Antibiotics use within the previous 14 days
Pregnant or lactating women
Significant chronic disorders like severe cardiac disease (NY functional state score>3), renal disease (creatinine>3 mg/dL), pulmonary disease (shortness of breath at rest or need for oxygen use), active infection, or other organ system disease requiring medical visits > 3 times /year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Keshavarzian, M.D.
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24557009
Citation
Jedel S, Hoffman A, Merriman P, Swanson B, Voigt R, Rajan KB, Shaikh M, Li H, Keshavarzian A. A randomized controlled trial of mindfulness-based stress reduction to prevent flare-up in patients with inactive ulcerative colitis. Digestion. 2014;89(2):142-55. doi: 10.1159/000356316. Epub 2014 Feb 14.
Results Reference
derived
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Mind/Body Medicine and IBD Flare-Up
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